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Analytical Specialist
2 weeks ago
We are seeking a skilled and detail-oriented Analytical Specialist with hands-on experience in HPLC to join our Quality Control team.
Key Responsibilities:- Conduct analytical testing of raw materials, in-process samples, and finished products with a primary focus on HPLC.
- Perform routine and non-routine analysis using HPLC for assay, dissolution, related substances, and stability studies.
- Preparation, review, and maintenance of test data, analytical records, and reports in compliance with GMP and GLP.
- Calibrate, operate, and troubleshoot HPLC and other analytical instruments.
- Evaluate and validate new methods and procedures as required.
Additional Responsibilities:
- Maintain proper documentation and data integrity in line with audit expectations.
- Ensure compliance with quality standards, SOPs, and regulatory requirements.
Requirements:
- Bachelor's or Master's degree in Analytical Chemistry, Pharmaceutical Chemistry, or related field.
- ~2–5 years of experience in a pharmaceutical QC lab.
- Strong hands-on experience in HPLC method execution and troubleshooting.
- Familiarity with regulatory guidelines (e.g., ICH, FDA).
- Working knowledge of LabSolutions/Chromeleon / Empower or similar HPLC software.
